A randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab versus dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent, or persistent cervical carcinoma (JCOG1311): Primary analysis.


Journal

Gynecologic oncology
ISSN: 1095-6859
Titre abrégé: Gynecol Oncol
Pays: United States
ID NLM: 0365304

Informations de publication

Date de publication:
08 2021
Historique:
received: 06 03 2021
accepted: 07 05 2021
pubmed: 22 5 2021
medline: 15 12 2021
entrez: 21 5 2021
Statut: ppublish

Résumé

To assess the efficacy and safety of dose-dense weekly paclitaxel plus carboplatin (ddTC) with or without bevacizumab compared to conventional, tri-weekly paclitaxel plus carboplatin (cTC) with or without bevacizumab, in metastatic or recurrent cervical carcinoma not amenable to curative local therapy. Patients were randomly assigned to either the cTC or ddTC arm. The cTC regimen was paclitaxel 175 mg/m jRCTs031180007. In total, 122 patients were randomly assigned to either the cTC arm (cTC + bevacizumab: 32; cTC:29) or the ddTC arm (ddTC+bevacizumab: 30; ddTC:31). The RR for patients on cTC + bevacizumab was 67.9%, and for patients on ddTC+bevacizumab 60.7%, cTC: 55.2%, and ddTC: 50.0%. The study did not meet the primary endpoint of phase II portion. Dose-dense, weekly paclitaxel plus carboplatin is not promising for metastatic or recurrent cervical carcinoma.

Identifiants

pubmed: 34016453
pii: S0090-8258(21)00403-0
doi: 10.1016/j.ygyno.2021.05.007
pii:
doi:

Substances chimiques

Bevacizumab 2S9ZZM9Q9V
Carboplatin BG3F62OND5
Paclitaxel P88XT4IS4D

Types de publication

Clinical Trial, Phase II Clinical Trial, Phase III Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

292-298

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest None of the authors reports that they have any conflict of interest to disclose.

Auteurs

Mitsuya Ishikawa (M)

Department of Gynecology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: miishika@ncc.go.jp.

Taro Shibata (T)

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.

Takashi Iwata (T)

Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.

Shin Nishio (S)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Toshio Takada (T)

Department of Obstetrics and Gynecology, Kitasato University School of Medicine, Kanagawa, Japan.

Shiro Suzuki (S)

Department of Gynecologic Oncology, Aichi Cancer Center Hospital, Aichi, Japan.

Koji Horie (K)

Department of Gynecology, Saitama Cancer Center, Saitama, Japan.

Wataru Kudaka (W)

Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus, Okinawa, Japan.

Masahiro Kagabu (M)

Department of Obstetrics and Gynecology, Iwate Medical University school of Medicine, Iwate, Japan.

Michihiro Tanikawa (M)

Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.

Ryo Kitagawa (R)

Department of Gynecology and Obstetrics, Moriya Daiichi General Hospital, Ibaraki, Japan.

Munetaka Takekuma (M)

Division of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.

Hiroaki Kobayashi (H)

Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Japan.

Nobuo Yaegashi (N)

Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Miyagi, Japan.

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Classifications MeSH